PMA P830061S109
- Device
- CAPSURE SENSE BIPOLAR LEAD 4074, CAPSURE SENSE BIPOLAR LEAD 4574
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P830061
- Supplement
- S109
- Product code
- NVY
- Decision date
- 2014-07-16
- Classification
- Permanent Defibrillator Electrodes
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- IMPLEMENTATION OF AN EQUIVALENT STERILIZER AND AERATOR.
Current openFDA PMA Record#
- Device
- CAPSURE SENSE BIPOLAR LEAD 4074, CAPSURE SENSE BIPOLAR LEAD 4574
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P830061
- Supplement
- S109
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2014-07-16
- Decision code
- OK30
- Date received
- 2014-06-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- IMPLEMENTATION OF AN EQUIVALENT STERILIZER AND AERATOR.